Clinical Trial: Iron Fortification Trail Using NaFeEDTA in Iron Deficient Lead-exposed Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Interactions of Lead Intoxication and Iron Deficiency in Morocco: The Effects of Iron Fortification With and Without NaEDTA on Lead Burden, Iron Status and Cognition in Ch

Brief Summary:

In a cross-sectional study allotted by the ethical committee of the ETH Zurich, we are investigating the extent of anemia, iron deficiency and lead intoxication in young children. For this purpose an assessment of body lead burden and iron status was conducted in a cohort of individuals residing in areas of presumed high lead exposure. Associations between lead burden and iron status will be investigated in the near future (current status of the study).

In a follow-on intervention study, the effect of iron fortification with and without NaEDTA on blood lead levels in lead-exposed children will be evaluated; and the relative impact of these two strategies on child growth, motor and cognitive test performance will be compared.

This study will investigate the potential use of iron fortification to not only combat anemia but also reduce body lead burden in lead-exposed populations; it specifically investigates whether iron fortification with NaFeEDTA could have additional beneficial effects to iron alone.

Detailed Summary:

Introduction Coexisting chronic lead poisoning and iron deficiency anemia (IDA) are common in urban areas in developing regions, particularly in young children. In urban Morocco, anemia affects more than 1/3rd of schoolchildren and lead exposure is high. Lead poisoning and IDA both impair cognitive development and educability and may therefore have substantial health, social and economic costs on developing countries.

Iron status alters susceptibility to gastrointestinal lead exposure; absorption of lead is sharply increased in children with IDA. IDA upregulates the divalent metal transporter trans-port protein (DMT-1) and increases lead absorption. Thus, iron fortification to reduce IDA may also reduce lead absorption and be an effective strategy to accompany environmental lead abatement. The optimal iron compound for wheat flour is currently debated, and although elemental iron compounds are commonly used, they may be only poorly absorbed in the face of inhibitory compounds found in wheat flour.

A form of chelated iron, NaFeEDTA, is a promising iron fortificant that is recommended for wheat flour fortification. It is also a lead chelator. It may be superior to other iron fortificants in its ability to reduce body lead burden, due to:

1. its iron is highly bioavailable in the face of dietary inhibitors (such as phytic acid in wheat flour); and
2. potentially, its ability to chelate lead in the gut and bloodstream. Thus, it may be a good choice for fortification of wheat flour in Morocco, particularly in urban areas, to both reduce IDA and lower body lead.

Study aims and objectives:

1. changes in blood lead levels over time of the intervention